The European Commission has proposed a regulation aimed at simplifying European Union (EU) rules related to medical and in vitro diagnostic devices, in a move that could affect thousands of businesses operating in the medtech sector.

In a statement on 16 December, the EU’s executive branch said its proposals would look to assist the digitalisation of procedures and “offer a coherent framework so that companies can respond to changing market conditions and patient needs.”

According to a Q&A published by the Commission, the planned changes include the introduction of maximum timelines for the completion of activities related to conformity assessments and clearer definitions to, among other things, enhance the legal certainty of certification.  

The Commission’s efforts to enact change could have a significant impact on SMEs. “There are more than 38,000 medical technology companies in Europe,” its Q&A said. “Of them, small and medium-sized enterprises make up around 90%, the majority of which employ fewer than 50 people,” it added.

“Altogether, the medical technology industry employs more than 930,000 people in Europe. Given their particular importance in this sector, the new rules will give special focus to the needs of these small companies.”

To further help SMEs, it’s envisaged that the European Medicines Agency – a decentralised agency of the EU – will provide “dedicated support” to offer guidance and advice on regulatory processes. In terms of next steps, the proposals will be submitted to the European Parliament and Council of the European Union for adoption.

“The EU is a global leader in medical devices,” Valdis Dombrovskis, the commissioner for economy and productivity and implementation and simplification, said. “Our rules must provide clarity, predictability and flexibility to sustain that leadership and continue delivering for patients,” he added.

“Today, we are simplifying procedures, cutting bottlenecks and strengthening regulatory certainty and predictability for manufacturers and public authorities, all while keeping patient safety as our top priority. This will speed up access to innovative medical devices and boost the competitiveness of a sector that is vital to Europe’s economy.”

Others reacting to the proposals included Oliver Bisazza, the CEO of trade association MedTech Europe. “This revision is a long-awaited and necessary step to fix parts of the EU regulatory system that are clearly not working for patients, innovators and healthcare providers,” he said.

“Significant system improvements are needed to make it more efficient, innovation friendly and well-governed,” he added.

“With the right reforms and investment, Europe can once again lead in inventing, launching and ensuring patient access to medical technology innovation. The task now for the European Parliament and the Council is to fully seize this opportunity in the final legislation.”

The plans for medical devices are part of a package consisting of a Biotech Act and Safe Hearts Plan, which are concerned with bolstering the EU’s biotechnology sector and tackling cardiovascular diseases.

EU exports of medicinal and pharmaceutical products hit €313.4bn in 2024, according to Eurostat, a 13.5% jump compared to 2023. Imports came in at €119.7bn, a rise of 0.5%. The bloc’s trade surplus for medicinal and pharmaceutical products amounted to €193.6bn, a record.